MAUDE Adverse Event Report: ARTHREX, INC. SPEEDBRG IMPL SYS W/ PEEK SWVLK SP; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SPEEDBRG IMPL SYS W/ PEEK SWVLK SP
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the spear came loose during a speed bridge operation when it was impacted into the bone.There was no harm for patient, operator or third party.It was not necessary to switch the surgical technique.***update nroe 06-nov-2023: further information revealed that the spear loosens from the handle during impaction.The surgery was finished successfully and the same device was used anyway.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-2600sbs-7 serial/batch number (b)(6) was received for investigation.Visual evaluation found that the punch shaft is firmly attached to the blue handle.The shaft length was measured by drawing specification (drawing c0795 at revision 8).Results: the shaft length is longer, most likely because of the movement of the shaft.During visual inspection, it was noted that the laser marks faded.This is an indication that the device was being re-sterilize and reused.This device is a single use.Functional testing for this part consisted of moving the shaft to verify the shaft was attached to the blue handle.The most likely cause for the reported failure is a user error to re-sterilize the device and reuse it, according to dfu-0309-eor2.E.Warning.4.Do not re-sterilize this device.10.This is a single-use device.Reuse of this device could result in failure of the device to perform as intended and could cause harm to the patient and/or user.

• Brand Name: SPEEDBRG IMPL SYS W/ PEEK SWVLK SP
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 18174370
• Report Number: 1220246-2023-08822
• Device Sequence Number: 18048746
• Product Code: MAI
• UDI-Device Identifier: 00888867160231
• UDI-Public: 00888867160231
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SPEEDBRG IMPL SYS W/ PEEK SWVLK SP
• Device Catalogue Number: AR-2600SBS-7
• Device Lot Number: 15117122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown